Submit in vitro study data and justify dose: CDSCO Panel Tells Akums Drugs on Veterinary Antibiotic FDC

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-04-06T05:00:08+05:30 | Updated On 6 April 2025 5:00 AM IST

Akums Drugs ink pact with global pharma firm

New Delhi: Responding to the proposal presented by Akums Drugs and Pharmaceutical regarding the veterinary antibiotic combination amoxycillin 3 gm plus clavulanic acid 600 mg, the Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has recommended the firm to submit and present the in vitro study data on efficacy, susceptibility, and justification for dose selection in target animals, maximum dose, schedule of dosing, and withdrawal period.

This came after Akum Pharmaceutical presented the proposal before the SEC committee.

Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Amoxicillin is a penicillin antibiotic. It is used to treat bacterial infections, such as chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers.

Clavulanic acid is a beta-lactam drug that prevents bacteria from destroying other antibiotics. It does this by binding to the active site of beta-lactamases, which are enzymes that break down antibiotics. This prevents the beta-lactamases from inactivating antibiotics like amoxicillin.

At the recent SEC meeting for veterinary held on 20th February 2025, the expert panel reviewed the proposal presented by Akums Drugs and Pharmaceutical.

After detailed deliberation, the committee recommended that the firm should submit the following and present the same in the next SEC meeting.

a) In vitro study data for efficacy, susceptibility, and minimum inhibitory concentration against the animal pathogens.

b) Justification for dose selection in target animals, maximum dose, schedule of dosing, and withdrawal period.

Also Read: CDSCO Panel Rejects Novo Nordisk Proposal to amend warning statement of Semaglutide Injection

akums drugs & pharmacdscoveterinary drugamoxycillin plus clavulanic acid

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751